The race for an effective COVID-19 treatment: Hunches, trials and no clear answer

As COVID-19 continues to take thousands of lives around the world each day, global efforts to find effective treatments are in hyperdrive.

So far, no treatment has been proved through rigorous scientific studies to do more good than harm — a crucial point often glossed over by President Donald Trump and some doctors who have promoted the alleged benefits of specific drugs. That leaves health care providers on the front lines to piece together their own strategies while research continues.

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“We’re really struggling to find the therapies for people who do get seriously ill, trying to save their lives,” said Dr. Richard Novak, professor and chief of infectious diseases at University of Illinois at Chicago Department of Medicine.

In seeking a safe treatment that works, scientists start with hunches, drawn from anecdotal evidence on certain drugs and therapies tried in China, where the COVID-19 outbreak first occurred, and other nations. Based on those educated guesses, they move on to clinical trials. Several Chicago hospitals are already involved in those efforts.

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A researcher at a University of Copenhagen research lab in Denmark works on a vaccine against the new coronavirus that causes COVID-19 on March 23, 2020. A team of about 10 researchers is working around the clock to develop a vaccine that could be tested through clinical trials within nine months. (Thibault Savary / AFP)

Medical researchers are also hunting for something even more important in containing and ending the pandemic: a vaccine that will protect people who haven’t contracted the disease.

But the arrival of a vaccine could be a year or more off, if it ever comes, so doctors, scientists and pharmaceutical companies continue to work on identifying an effective treatment for those who do get sick.

“If you don’t have a vaccine, you have to treat,” said Dr. Robert Gallo, co-founder and director of the Institute of Human Virology at the University of Maryland School of Medicine. “We don’t know when a vaccine will be available, absolutely don’t know ... and it could be never.”

The treatments being studied take several different approaches. They include suppressing the immune system, which seems to go into fatal overdrive in the worst cases; attacking the new coronavirus that causes COVID-19, known as SARS-CoV-2; introducing the antibodies of recovered patients into people who are still fighting the disease; and tamping down production of a chemical in the body that may exacerbate the illness.

Although some approaches have shown at least limited promise, it will take months of further study through larger clinical trials to see what truly works. “We don’t know if we’re going to have a home run or a base hit with any of these drugs at this moment,” cautioned Dr. Gregory Huhn, an infectious disease physician at Stroger Hospital, where the antiviral drug remdesivir is being tried on patients as part of a larger clinical trial.

Here are some of the more prominent potential treatments that are being studied:

Hydroxychloroquine

This is the malaria-fighting drug, sold under the brand name of Plaquenil, that Trump has touted during White House briefings on the battle against COVID-19.

“What do you have to lose? Take it,” Trump famously said. "I really think (patients) should take it. But it’s their choice and it’s their doctor’s choice, or the doctors in the hospital. But hydroxychloroquine — try it, if you’d like.”

President Donald Trump and his administration have touted the anti-malaria drug hydroxychloroquine as a treatment for COVID-19, though it has not been officially approved for those patients. (John Locher / AP)

What you could have to lose is your life, given that the drug can cause or exacerbate cardiac arrhythmia — an irregular heartbeat that in some cases can lead to a stroke or a heart attack.

Despite the risks, and despite the lack of scientific proof that the drug is effective in treating COVID-19, its use has also been touted by a French doctor and another from New York state, to controversial effect.

Hydroxychoroquine, and its cousin chloroquine, work by suppressing the immune system. In some people afflicted with COVID-19, the immune system produces a tsunami of antibodies that floods the lungs and essentially drowns the victim. The thought is that doctors may be able to prevent that fatal response by using the drug.

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In both the clinical trials and in the treatment of individual patients that the Food and Drug Administration has allowed under “compassionate use” guidelines, the drug often is paired with the antibiotic azithromycin — better known as Z-Pak — to prevent fluid in the lungs from causing a secondary bacterial infection.

But taking the drug carries its own dangers.

In announcing one clinical trial of hydroxychloroquine, the National Institutes of Health warned: “The drug is not without risks as even short-term use can cause cardiac arrhythmias, seizures, dermatological reactions and hypoglycemia."

In addition to treating malaria, hydroxychloroquine is used to treat autoimmune disorders, such as lupus and rheumatoid arthritis, and pharmacists are concerned that hoarding of the drug amid the current hype will make it unavailable to patients with those conditions.

Remdesivir

The drug is undergoing several trials, with at least four Chicago hospitals taking part by testing it on moderately and severely ill COVID-19 patients. They include Northwestern Memorial Hospital, University of Illinois Hospital and Rush University Medical Center, all of which are participating in a scientific study sponsored by the National Institutes of Health.

Vials of the drug remdesivir are displayed at a news conference about the start of a study to use the drug in severely ill coronavirus patients at the University Medical Center Eppendorf in Hamburg, Germany, on April 8, 2020. (Ulrich Perrey/AFP)

The Cook County Health and Hospitals System, which includes Stroger Hospital, is taking part in a study sponsored by Gilead, the drug’s maker.

“In animal models, in monkey models, the drug works by directly inhibiting the virus’s ability to replicate in high numbers,” explained Huhn, the infectious disease specialist at Stroger. “In humans, we believe it works by the same mechanism to limit the amount of virus that can be accelerated in high numbers throughout the body that can lead to lung damage.”

Huhn said it’s way too early to tell how well the intravenous drug will work, but some early signs give him hope.

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“Among the numerous patients that we’ve enrolled, we’ve had a handful that have been discharged already off oxygen,” Huhn said. “So, very much too early to tell, but certainly when any patient is discharged off oxygen, that’s an encouraging sign to us.”

Novak, the UIC infectious disease chief, said the drug may be more effective on patients whose disease is less serious. “My feeling, and I could be wrong on this, is that it’s probably going to help people with earlier disease who enroll in the study rather than people with more advanced disease,” he said.

As with hydroxychloroquine, remdesivir has also been prescribed by some doctors outside of the studies under the compassionate use exception, but that exception has since been limited to pregnant women and people under the age of 18, Huhn said.

Convalescent plasma

Doctors describe infusions of plasma from recovered patients as an “ancient” treatment, given that it dates back a century or so.

The idea is that surviving patients have developed antibodies that target and defeat the virus, and introducing them into sick patients will help fight the disease.

Tocilizumab

Marketed under the brand name of Actemra, the drug is currently used to treat rheumatoid arthritis and other ailments. It works by inhibiting interleukin 6, a protein that is involved in the immune response and can cause swelling, including the type of lung inflammation seen with COVID-19.

“I talked to one physician who said a person was in really bad shape and after 24 to 48 hours (of tocilizumab treatment) was jumping around," Gallo said, adding that he holds out more hope for this treatment than the others, particularly those who are severely ill with the disease.

The Global Virus Network, which Gallo co-founded and where he serves as international scientific adviser, will be involved in trials of the drug, he said.

Gallo said there also are many more potential treatments in the pipeline, including one that is expected to be announced soon. He described it as a “novel vaccine" that is “something that is possibly going to be therapeutic as well.” He declined to discuss it further before the announcement.

Despite all the ongoing efforts, doctors and scientists stress that no treatment for COVID-19 has been proved to help patients without causing too much harm.

“If my family member ever got this, I would not tell them to use any of those things, truthfully, unless it was really life threatening, and on the ventilator, and we’ve done everything else we could,” said Dr. Rahul Khare, founder and CEO of Innovative Express Care, an immediate care clinic on the North Side.

“I would then ask the (infectious disease) specialist if he thinks this is the time to try it, because truthfully we don’t know enough, and it could do more harm than good," Khare added. "And the studies that have been out are not convincing, that’s for sure.”

Vaccines

Novak, the infectious disease specialist at UIC, said development of a vaccine is crucial. “A vaccine will be the main strategy that will allow us to prevent the disease and ultimately stop the pandemic,” he said.

But Gallo and others noted there is no guarantee one will be found.

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“We don’t know” when a vaccine will come, “and it could be never,” Gallo said. “But one thing is for sure: It’s not going to be in five months or eight months or 12 months, because it takes time to prove and get efficacy and safety proven."

Khare noted that despite many years of efforts, there are no vaccines for some viruses, such as the ones that cause AIDS and herpes. “My hope is that we get (a vaccine), but I also know that it’s not as easy as the influenza vaccine that we get every year,” he said.

Novak said he’s optimistic that the efforts will succeed, in part because the new coronavirus appears to be a far better target for a vaccine than AIDS-causing HIV, which mutates furiously and continuously, making it extremely difficult if not impossible to target.

“This is different,” he said. “It doesn’t mutate very rapidly, and there are some pretty good targets for a vaccine. The virus has some weaknesses that can be targeted.”

“We are so far ahead of where we were 20 years ago, in terms of our ability to figure out vaccines and make them. I’m pretty confident we are going to have a vaccine for this virus.”